MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION CATHETER; SWAN-GANZ CATHETER

Model Number 131F7J

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital due to infection.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.There are multiple failure modes that may require the exchange of a pacing catheter.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.Stretching, kinking, or forceful wiping of the catheter may result in damage.After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration.Care should be taken not to kink the catheter body when securing it.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that the indicated cardiac output (co) value was higher than the expected value on the first day of use.The indicated value was from 9 to 10 l/minute and the expected was 5 l/minute.The customer checked the connection and multiple measurements were attempted, however, the problem was not solved.The catheter was exchanged and the problem was solved.It is unknown if an error message was observed or if there was an occlusion, leakage or kink noted in the catheter.It is unknown if the value was affected by the patient condition.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8921337
• MDR Text Key: 192204118
• Report Number: 2015691-2019-03115
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1